MAUDE Adverse Event Report: ARTHREX, INC. IMPLSYS,FT T-RPII,RTT-IB,FCIII,FBRLINK; NON-DEGRADABLE FIXATN FASTENER

Model Number	IMPLSYS,FT T-RPII,RTT-IB,FCIII,FBRLINK
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 1/13/2025 it was reported by a sales representative via email that the needle attached to the fibertag tightrope from an ar-1288rtt2-fc3 fibertag tightrope ii for internalbrace implant system broke off the suture.The suture could not pass through the mechanism of the fibertape.This was discovered during a quad autograft acl procedure on (b)(6) 2025.The case was completed using another ar-1288rtt2-fc3 fibertag tightrope ii for internalbrace implant system.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex concluded that the most likely cause of the reported failure is user error, including excessive force shortening suture strands and/or tensioning the shortening suture strands not in-line with the bone socket may break the strands.The complaint allegation was not confirmed, and no evidence of the failure was received.

• Brand Name: IMPLSYS,FT T-RPII,RTT-IB,FCIII,FBRLINK
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 21320795
• Report Number: 1220246-2025-00231
• Device Sequence Number: 18317130
• Product Code: MBI
• UDI-Device Identifier: 00888867430341
• UDI-Public: (01)00888867430341(11)240520(17)280531(10)15250695
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K241235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IMPLSYS,FT T-RPII,RTT-IB,FCIII,FBRLINK
• Device Catalogue Number: AR-1288RTT2-FC3
• Device Lot Number: 15250695
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown